Status:
TERMINATED
Wearable Auscultation Device Validation in Children
Lead Sponsor:
Strados Labs, Inc.
Conditions:
Asthma
Asthma in Children
Eligibility:
All Genders
4-17 years
Brief Summary
This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, sur...
Eligibility Criteria
Inclusion
- Any child aged 4-17 years of age
- Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
- Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
- Admitted for a non-respiratory complaint
- Normal breath sounds on screening examination
- Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
- Admitted for pathologic process that may lead to wheezing (e.g., asthma)
- Presence of wheeze on screening examination
Exclusion
- Children less than age 4, adults (age 18 and above)
- Patients in the ambulatory setting
- Unable to provide consent
- Intubated patients
- Unstable disease posing a threat to life
- Adhesive allergy
Key Trial Info
Start Date :
August 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06112080
Start Date
August 7 2023
End Date
June 24 2024
Last Update
July 5 2024
Active Locations (1)
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1
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611